Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus

University Hospital, Rouen90 enrolled

Overview

Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients. The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pemphigus Disease

Interventions

for patients with severe pemphigus : general corticotherapy Arm : 1.5mg/kg/d for 1 month, then 1.25mg/kg/d for 1 month, then 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 3 months, then 0.3 mg/kg/d for 3 months, then 0.2 mg/kg/d for 4 months, then 0.1 mg/kg/d for 4 months, for patients with moderated pemphigus : general corticotherapy Arm : 1mg/kg/d for 1 month, then 0.75mg/kg/d for 1 month, then 0.5mg/kg/d for 2 months, then 0.3 mg/kg/d for 2 months, then 0.2 mg/kg/d for 3 months, then 0.1 mg/kg/d for 3 months,

RituximabDRUG

for patients with severe pemphigus : rituximab Arm : 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 1 month, then 0.3 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month, then 0.1 mg/kg/d for 1 month for patients with moderated pemphigus : rituximab Arm : 0.5mg/kg/d for 1 month, then 0.30 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month,

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \>=18 and \<= 80years * consent obtained from patient * effective female contraceptive method for women in procreate age * new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF) Exclusion Criteria: * pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated * pregnant woman or nursing mother * woman able to have a baby and without contraception during the clinical trial period * age \< 18 or \> 80 * karnovsky \< 50% * serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody * patient with depletion lymphocytic treatment in the next month * unstable angina or ischemic heart disease * cardiac insufficiency * cardiac rhythm trouble uncontrolled * positive HIV serology * positive hepatitis B and / or C serology * no consent

Outcomes

Primary Outcomes

Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment

Time frame: 2 years

Secondary Outcomes

Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment

Time frame: 6 months